MAUDE Adverse Event Report: MOTION CONCEPTS LP POWERED WHEELCHAIR SYSTEM

Model Number	45T-12L-RESR-MAXX
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	01/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On (b)(6) 2018, the mentioned wheelchair was shipped to (b)(4) (motion distributor) and then on (b)(6) 2020, it was shipped to va medical center (b)(4)dealer) at (b)(6) according to the specification provided by the client.As per our record, we had received a complaint for the left side arm and replacement was sent to the dealer on (b)(6) 2020, which the dealer replaced the arm.This mentioned adverse event happened on (b)(6) 2020, was caused while transferring and it happened on the left side gel arm pad which the dealer replaced.As motion concepts haven't received any similar complaint as this arm pad issue and we haven't received the part back for evaluation, we assume that this issue might have caused due to dealer installation error.At this time, based on the mix of information we have received, we are not able to isolate the root cause of this issue.
Event or Problem Description
On (b)(6) 2020, motion concepts lp was notified by (b)(4) ( motion concepts importer) that, one of (b)(4) dealers (vamc) notified them about an incident that took place on (b)(6)2020.The dealer stated that the end-user was transferring from his wheelchair and when he grapped the gel armpad, the armpad pulled off and he fell to the floor and fractured his leg.The end user has to put in pins and brace because of the fracture.The dealer stated that the chair was going to be evaluated at the hospital but the end-user refused to take the drug-screen.

• Brand Name: POWERED WHEELCHAIR SYSTEM
• Common Device Name: WHEELCHAIR
• Manufacturer (Section D): MOTION CONCEPTS LP; 84 citation drive; unit 1-12; concord, ontario L4K 3 C1; CA L4K 3C1
• MDR Report Key: 10008937
• Report Number: 9615350-2020-00004
• Device Sequence Number: 2750522
• Product Code: ITI
• UDI-Device Identifier: 00754014710065
• UDI-Public: 00754014710065
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K150574
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Model Number: 45T-12L-RESR-MAXX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Weight: 86